A Japanese multicenter phase II study of adjuvant chemotherapy with mFOLFOX6/CAPOX for stage III colon cancer treatment after D2/D3 lymphadenectomy
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A phase II trial was conducted to investigate the benefit of oxaliplatin-based adjuvant chemotherapy in Japanese stage III colon cancer patients.
Eligible patients were scheduled to receive 12 cycles of mFOLFOX6 or 8 cycles of CAPOX in adjuvant settings. The primary endpoint was the 3-year disease-free survival (DFS). Cox proportional hazards regression was performed to identify risk factors for a worse DFS.
A total of 130 patients, including 73 patients receiving mFOLFOX6 and 57 patients receiving CAPOX, were enrolled from 16 institutions between April 2010 and April 2014. The 3-year DFS was 82.2%, exceeding the expected primary endpoint of 81.7%. The 3-year DFS tended to be higher in patients receiving mFOLOFOX6 than in those receiving CAPOX (mFOLFOX6, 86.3%; CAPOX, 76.9%; P = 0.06). The 3-year DFS rates did not differ markedly based on the risk stratification (T1/T2/T3 N1 vs. T4 or N2) indicated by the IDEA COLLABORATION study (P = 0.22). In the multivariate analysis, stage IIIC (P = 0.046) and early discontinuation (P < 0.01) were identified as independent significant risk factors for a worse DFS.
Our findings represent the first positive results in a Japanese phase II trial of adjuvant chemotherapy with mFOLFOX6/CAPOX. Early discontinuation within 2 months was an independent risk factor for a shorter DFS.
KeywordsStage III colon cancer Adjuvant chemotherapy mFOLFOX6 CAPOX Early discontinuation
We appreciate the help of Dr. Tomoyuki Kawada in supervising the biostatistical analysis. We also thank Drs. Nobuhiro Takiguchi, Shigehisa Mori, Hisato Osada, and Noboru Oriuchi for their useful advice.
Compliance with ethical standards
Conflict of interest
Keiichiro Ishibashi, Hiroyuki Kato, Michiya Kobayashi and Hideyuki Ishida received a research grant from Yakult Co., Ltd. and Chugai Pharmaceutical Co., Ltd. Masatoshi Oya received a research grant from Yakult Co., Ltd., and Hiroshi Maekawa received a research grant from Chugai Pharmaceutical Co., Ltd. The other authors have no conflicts of interest to declare.
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